A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.
Checked against the public recordLast updated May 28, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Eikon Therapeutics
- Interventions being studied
- Drug: EIK1001; Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. be ≥ 18 years of age on the day of signing of informed consent. 2. confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care. 3. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy). 4. have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment. 5. have not received prior systemic treatment for advanced/metastatic NSCLC. 6. have an ECOG Performance Status of 0 to 1. 7. have adequate organ function. Exclusion Criteria: 1. does not have predominantly squamous cell or non-squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. 2. is currently participating in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001. 3. prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (\< 3 weeks prior to the first dose). 4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration. 5. has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years. 6. has an active infection requiring therapy.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Southern Cancer CareDaphne, Alabama
- Ironwood Cancer and Research CenterChandler, Arizona
- California Cancer Care Associates for Research & ExcellenceFresno, California
- California Research InstituteLos Angeles, California
- University of Southern California, Norris Comprehensive Cancer CenterLos Angeles, California
- Providence St Joseph Hospital, Center for Cancer Prevention and TreatmentOrange, California
- Sutter Health Institute for Medical ResearchSacramento, California
- Rocky Mountain CancerLone Tree, Colorado
- Bioresearch PartnerHialeah, Florida
- Memorial Cancer InstituteHollywood, Florida
- Mid-Florida Hematology and Oncology CenterOrange, Florida
- Orlando Health Cancer InstituteOrlando, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 28, 2026. Always confirm current availability with the study team.